Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients.

This is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene,

Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses),

At least 1 physiotherapy session per week already in place.

Understanding of the protocol

Disqualifiers

Botulinum toxin injection within 2 months of protocol inclusion

Discontinuation of private physiotherapy,

Refusal to participate in the protocol,

Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • intensive reeducation

    Other intervention

    * 1 group physiotherapy session per week at the ICM or by videoconference from home for 6 weeks * 2 sessions per week at home with video support sent by e-mail for 6 weeks

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: the reeducation groupExperimental treatment 1 intervention
Group B: The control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.

6-minute walk test carried out in the presence of a clinician trained in this test. The patient walks for 6 minutes on a circuit of known distance, identical for each patient. The clinician times the walking time and measures the distance covered during 6 minutes. This test is performed at inclusion and again at 6 weeks

Time frame
6 weeks

Secondary outcomes

1

compare the before-after variation in distance covered in 6 minutes

6-minute walk test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks

Time frame
18 weeks
2

compare the before-after variation in walking speed over a 10-meters test

10-meters test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks

Time frame
18 weeks
3

compare the clinical evolution of spasticity

clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)

Time frame
18 weeks
4

compare the lower-limb joint amplitudes

clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale

Time frame
18 weeks

Other outcomes

Sponsors and contacts

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